Biosimilars Law in Flux
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An update on U.S. biosimilars in presentation to Life Science Association of Manitoba on October 13, 2011
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What is biologic, biosimilar, and biobetter
Biologics (eg, vaccines, blood and blood components, somatic cells, gene therapy, tissues, therapeutic proteins) are regulated by the US Food and Drug Administration (FDA). Biologics/Biosimilars/Biobetters are widely used to diagnose, prevent, treat, and cure diseases and medical conditions.
Naveen Kumar Singh received his B.Sc. in Biotechnology (2007) at University of Pune (Pune, India), M.Sc. in Biotechnology (2009) at Jaipur National University (Jaipur, India), and Ph.D. in Biochemical Engineering (2016) at Jacobs University Bremen (Bremen, Germany).
During his Ph.D., Naveen worked under the supervision of Prof. Marcelo Fernández-Lahore. His research dealt with designing experiments for developing fiber-based and cryogel-based adsorbents for capturing large therapeutic biomolecules (proteins, plasmids, and monoclonal antibodies). He had successfully evaluated the in-house fiber- and cryogel-based chromatographic adsorbents with the commercially available adsorbents and the in-house adsorbents had shown similar or higher productivities compared to the commercial adsorbents.
In February 2017, Naveen joined the group of Prof. Merlin L. Bruening in the Department of Chemical and Biomolecular Engineering at the University of Notre Dame as a Postdoctoral Research Associate. His current research focuses on developing novel bioseparation processes by introducing polyelectrolyte multilayer films onto membranes/monoliths for the purification of biotherapeutics like monoclonal antibodies.
Publications:
N. K. Singh, et al, “Preparation and Characterization of Grafted Cellulosic Fibers and their Applications in Protein Purification“, Sep. Purif. Technol., 143 (2015) pp. 177–183. https://www.sciencedirect.com/science/article/pii/S1383586615000714
N. K. Singh, et al, “Direct Capture of His6-tagged Proteins Using Megaporous Cryogels Developed for Metal-ion Affinity Chromatography“, inAffinity Chromatography (Ed.: S. Reichelt), Spinger, New York, USA, Methods in Molecular Biology, 1286 (2015) pp. 201–212. http://link.springer.com/protocol/10.1007/978-1-4939-2447-9_16
N. K. Singh, et al, “Gamma ray mediated functionalization of monolithic cryogels for macro-biomolecule purification“, N. Biotechnol., 31, Supplement (2014) pp. S127. http://www.sciencedirect.com/science/article/pii/S1871678414019906
N. K. Singh, et al, “High capacity cryogel-type adsorbents for protein purification“, J. Chromatogr. A, 1355 (2014) pp. 143–148. https://www.sciencedirect.com/science/article/pii/S0021967314008899
N. S. Bibi, N. K. Singh, et al, “Synthesis and performance of megaporous immobilized metal-ion affinity cryogels for recombinant protein capture and purification“, J. Chromatogr. A, 1272 (2013) pp. 145–149. https://www.sciencedirect.com/science/article/pii/S0021967312017670
Blog articles:
What are cryogels? https://www.biochemadda.com/cryogels-monolith-ion-exchange-affinity-chromatography/
U.S. Regulation of Biosimilars
Presentation at the Biosimilars and Follow-On Biologics 2014 Americas Conference, sponsored by Paradigm Global Events, February 12, 2014. Presentation focused on:
•Interchangeability
•State Substitution Laws
•Naming
•Risk Evaluation & Mitigation Strategies (REMS) and Their Impact on Biosimilars
•Where FDA Stands on Biosimilars
Biosimilars-emerging market in india
Hi all, with the rigorous secondary research for almost one month helped me to understand basic things about biosimilars and made me do this presentation. Hope u will appreciate it while going through it. thanks.
If anyone in need of this presentation, pls.put ur emial ID in comment box. will be sharing. and please share your thoughts about the presentation. i will be more thankful.
Jennifer DiGiacinto, "Biosimilars & BioBetters - The Differences Between Both...
Jennifer DiGiacinto, "Biosimilars & BioBetters - The Differences Between Both...The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics
February 7, 2017
Many of today’s important medications are biological products made from living organisms, manufactured through biotechnology, derived from natural sources, or produced synthetically. Biosimilars are a type of biological product approved by FDA on the basis of being highly similar to an already approved biological reference product.
This panel of experts discussed the current state of biosimilars in the healthcare ecosystem and what comes next from a technical and legal perspective. Topics included how the next generation of biosimilars could improve patient access to standard-of-care therapies, the concept of “biobetters,” economic and intellectual property considerations, and policy approaches to support existing and future biosimilars.
Learn more on our website: http://petrieflom.law.harvard.edu/events/details/looking-forwardUpdate on U.S. Regulation of Biosimilars
This document summarizes key issues regarding U.S. regulation of biosimilars, including the filing of the first biosimilar applications, requirements for demonstrating interchangeability, state substitution laws, challenges around naming conventions, and arguments on both sides of the naming debate. Industry is pursuing clinical trial designs aimed at demonstrating interchangeability, while FDA guidance is pending and naming remains controversial with pros arguing it ensures traceability and cons arguing it reduces biosimilar uptake.
Biosimilars
- Biosimilars are biologic medical products that are similar but not identical copies of original biologic drugs. They are developed when the patent expires on the original product.
- Regulatory agencies have stringent approval criteria for biosimilars to demonstrate similar quality, safety and efficacy as the reference product. Clinical trials must show comparable pharmacokinetics, pharmacodynamics and immunogenicity.
- While biosimilars increase access and lower costs, they are not generic copies and have unique safety profiles. Automatic substitution is not appropriate and unique nonproprietary names and labeling is required to facilitate pharmacovigilance.
BIOSIMILARS.pptx
introduction to biosimilar drug
difference between biosimilars and generic drugs
global scenarios
Indian scenario
conclusion
Strategies for Developing & Commercializing Biobetters & Biosimilars
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What is biologic, biosimilar, and biobetter
Biologics (eg, vaccines, blood and blood components, somatic cells, gene therapy, tissues, therapeutic proteins) are regulated by the US Food and Drug Administration (FDA). Biologics/Biosimilars/Biobetters are widely used to diagnose, prevent, treat, and cure diseases and medical conditions.
Naveen Kumar Singh received his B.Sc. in Biotechnology (2007) at University of Pune (Pune, India), M.Sc. in Biotechnology (2009) at Jaipur National University (Jaipur, India), and Ph.D. in Biochemical Engineering (2016) at Jacobs University Bremen (Bremen, Germany).
During his Ph.D., Naveen worked under the supervision of Prof. Marcelo Fernández-Lahore. His research dealt with designing experiments for developing fiber-based and cryogel-based adsorbents for capturing large therapeutic biomolecules (proteins, plasmids, and monoclonal antibodies). He had successfully evaluated the in-house fiber- and cryogel-based chromatographic adsorbents with the commercially available adsorbents and the in-house adsorbents had shown similar or higher productivities compared to the commercial adsorbents.
In February 2017, Naveen joined the group of Prof. Merlin L. Bruening in the Department of Chemical and Biomolecular Engineering at the University of Notre Dame as a Postdoctoral Research Associate. His current research focuses on developing novel bioseparation processes by introducing polyelectrolyte multilayer films onto membranes/monoliths for the purification of biotherapeutics like monoclonal antibodies.
Publications:
N. K. Singh, et al, “Preparation and Characterization of Grafted Cellulosic Fibers and their Applications in Protein Purification“, Sep. Purif. Technol., 143 (2015) pp. 177–183. https://www.sciencedirect.com/science/article/pii/S1383586615000714
N. K. Singh, et al, “Direct Capture of His6-tagged Proteins Using Megaporous Cryogels Developed for Metal-ion Affinity Chromatography“, inAffinity Chromatography (Ed.: S. Reichelt), Spinger, New York, USA, Methods in Molecular Biology, 1286 (2015) pp. 201–212. http://link.springer.com/protocol/10.1007/978-1-4939-2447-9_16
N. K. Singh, et al, “Gamma ray mediated functionalization of monolithic cryogels for macro-biomolecule purification“, N. Biotechnol., 31, Supplement (2014) pp. S127. http://www.sciencedirect.com/science/article/pii/S1871678414019906
N. K. Singh, et al, “High capacity cryogel-type adsorbents for protein purification“, J. Chromatogr. A, 1355 (2014) pp. 143–148. https://www.sciencedirect.com/science/article/pii/S0021967314008899
N. S. Bibi, N. K. Singh, et al, “Synthesis and performance of megaporous immobilized metal-ion affinity cryogels for recombinant protein capture and purification“, J. Chromatogr. A, 1272 (2013) pp. 145–149. https://www.sciencedirect.com/science/article/pii/S0021967312017670
Blog articles:
What are cryogels? https://www.biochemadda.com/cryogels-monolith-ion-exchange-affinity-chromatography/
U.S. Regulation of Biosimilars
Presentation at the Biosimilars and Follow-On Biologics 2014 Americas Conference, sponsored by Paradigm Global Events, February 12, 2014. Presentation focused on:
•Interchangeability
•State Substitution Laws
•Naming
•Risk Evaluation & Mitigation Strategies (REMS) and Their Impact on Biosimilars
•Where FDA Stands on Biosimilars
Biosimilars-emerging market in india
Hi all, with the rigorous secondary research for almost one month helped me to understand basic things about biosimilars and made me do this presentation. Hope u will appreciate it while going through it. thanks.
If anyone in need of this presentation, pls.put ur emial ID in comment box. will be sharing. and please share your thoughts about the presentation. i will be more thankful.
Jennifer DiGiacinto, "Biosimilars & BioBetters - The Differences Between Both...
Jennifer DiGiacinto, "Biosimilars & BioBetters - The Differences Between Both...The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics
February 7, 2017
Many of today’s important medications are biological products made from living organisms, manufactured through biotechnology, derived from natural sources, or produced synthetically. Biosimilars are a type of biological product approved by FDA on the basis of being highly similar to an already approved biological reference product.
This panel of experts discussed the current state of biosimilars in the healthcare ecosystem and what comes next from a technical and legal perspective. Topics included how the next generation of biosimilars could improve patient access to standard-of-care therapies, the concept of “biobetters,” economic and intellectual property considerations, and policy approaches to support existing and future biosimilars.
Learn more on our website: http://petrieflom.law.harvard.edu/events/details/looking-forwardUpdate on U.S. Regulation of Biosimilars
This document summarizes key issues regarding U.S. regulation of biosimilars, including the filing of the first biosimilar applications, requirements for demonstrating interchangeability, state substitution laws, challenges around naming conventions, and arguments on both sides of the naming debate. Industry is pursuing clinical trial designs aimed at demonstrating interchangeability, while FDA guidance is pending and naming remains controversial with pros arguing it ensures traceability and cons arguing it reduces biosimilar uptake.
Biosimilars
- Biosimilars are biologic medical products that are similar but not identical copies of original biologic drugs. They are developed when the patent expires on the original product.
- Regulatory agencies have stringent approval criteria for biosimilars to demonstrate similar quality, safety and efficacy as the reference product. Clinical trials must show comparable pharmacokinetics, pharmacodynamics and immunogenicity.
- While biosimilars increase access and lower costs, they are not generic copies and have unique safety profiles. Automatic substitution is not appropriate and unique nonproprietary names and labeling is required to facilitate pharmacovigilance.
BIOSIMILARS.pptx
introduction to biosimilar drug
difference between biosimilars and generic drugs
global scenarios
Indian scenario
conclusion
Strategies for Developing & Commercializing Biobetters & Biosimilars
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Clinical development of biopharmaceuticals in India
This document discusses the regulatory requirements for clinical development of biosimilars in India. It provides an overview of the applicable regulations, guidelines, and authorities overseeing clinical trials. The key principles for developing biosimilars are to demonstrate comparability to the reference biologic through a stepwise characterization and clinical development program involving pharmacokinetic, pharmacodynamic, and confirmatory safety and efficacy studies. Post-marketing requirements include pharmacovigilance plans and potential post-marketing studies to further evaluate safety and immunogenicity.
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This document provides an overview of biosimilars and their regulatory framework. It begins with definitions of biologics and biosimilars. Biosimilars are highly similar versions of approved biologics whose patents have expired. The development of biosimilars is unique compared to small molecule generics due to the complex nature of biologics. The document then discusses issues with biosimilars including potential efficacy, safety and substitution concerns. Finally, it provides details on the regulatory frameworks and guidelines established by organizations like WHO, EU, US and India to help facilitate the development and approval of biosimilars.
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This document discusses biosimilars and their regulation. It begins with a brief history of biotechnology and biopharmaceuticals. It then defines biosimilars as similar but not generic versions of biologic drugs whose patents have expired. The document outlines key differences between biosimilars and generic drugs, including their larger and more complex molecular structures. It also discusses concerns regarding biosimilar efficacy, safety, interchangeability, and pharmacovigilance. Finally, it provides an overview of regulatory frameworks for biosimilars in various regions like the EU, US, India, and WHO guidelines.
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1. The global biosimilars market is expected to grow significantly in the coming years due to various drivers such as patent expiries of major biologics and increasing cost containment pressures.
2. Indian companies are well positioned in the biosimilars space due to their established low-cost manufacturing capabilities and expertise in biologics. Key players in India include Dr. Reddy's, Biocon, Cipla and Intas.
3. Developing biosimilars presents several challenges including high development costs, complex clinical trials and unclear regulatory guidelines. Indian companies strategy involves partnerships for cost-effective development and leveraging domestic capabilities and emerging markets for growth.
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Sharing my learning in dealing with complexity and uncertainty and shed some light on:
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(b) Accelerating our “QbD” Journey – focusing on ‘from Generics to Biosimilars’
(c) In preparing this talk, collect my thoughts to help NIPTE consider ways for developing its program on Biosimilars to help the Nation improve assurance of quality with confidence and lower costs
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This document provides an overview of biological products as defined by the FDA. It describes biological products as medical products made from sugars, proteins, nucleic acids or complex combinations in living cells or tissues. Examples like vaccines, blood components and monoclonal antibodies are provided. The document highlights how biological products differ from chemically synthesized drugs in being large molecules from natural sources, requiring complex manufacturing processes, and sometimes being heterogeneous or immunogenic. It briefly outlines the process required for a biological product to be licensed by the FDA, including demonstrating consistent manufacturing and clinical safety and efficacy data.
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This document provides a summary of the biosimilars pipeline in India over the next 3-5 years. It describes several biologic drugs whose patents will expire such as Avastin, Herceptin, Humira, Erbitux, and Remicade. The objective is to understand the competitive landscape as many global and Indian companies are aggressively developing biosimilars for these drugs. The document then provides details of an ongoing clinical trial in India of a rituximab biosimilar being developed by Hetero Drugs for the treatment of non-Hodgkin's lymphoma.
Biosimilars
Biosimilars are biopharmaceutical drugs that are similar to an original biologic drug, but are manufactured when the original drug's patent expires. Biosimilars must demonstrate similarity to the original product in terms of quality, safety and efficacy. India has advantages in manufacturing biosimilars due to lower costs and skilled workforce. Major Indian companies are developing biosimilars and targeting both domestic and international markets like the US and EU. Regulatory authorities in India approve and regulate biosimilars to ensure their safety and efficacy.
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This document discusses biosimilars in India and the opportunities and challenges in the biosimilars industry in India. It defines biosimilars and provides an overview of the global and Indian biosimilars market and regulatory landscape. The key opportunities for India include providing affordable treatment options and commercial benefits from lower cost manufacturing. However, challenges include regulatory hurdles, concerns around quality and safety, high development costs, and physician reluctance to prescribe biosimilars.
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This document provides an overview of biosimilars including their advantages and disadvantages. It discusses regulatory guidelines for biosimilar approval in India, challenges in biosimilar development and production, and recently approved biosimilars. The conclusion recognizes biosimilars as an important part of the pharmaceutical ecosystem but one that faces barriers to adoption such as questions of interchangeability and not having approval for all reference product indications. It recommends overcoming challenges to biosimilar market access.
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1) The guidelines define biosimilars as biological products claimed to be similar in safety, efficacy, and quality to an approved reference biologic.
2) Biosimilars are developed through analytical studies comparing properties to the reference product, which could reduce required clinical testing.
3) Clinical testing may include pharmacokinetic, pharmacodynamic, and safety/efficacy studies designed to establish comparability to the reference product. Post-market surveillance is also required.
4) The guidelines aim to balance regulatory standards with access to affordable biologics through a biosimilars pathway
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Biosimilars are biotherapeutic products that are similar to already approved reference biologics in terms of quality, safety and efficacy. They are developed to be highly similar but not identical to existing biologics. Regulatory agencies like EMA and FDA require extensive analytical, non-clinical and clinical studies including pharmacokinetic, immunogenicity and clinical efficacy trials to establish biosimilarity. While biosimilars could increase access and lower costs, issues related to efficacy, safety, substitution and labeling need to be addressed to ensure patient safety and appropriate use.
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This document summarizes strategies for developing and manufacturing biosimilars. It discusses Hospira's biosimilars business and development network. Biosimilars have distinct development challenges compared to generics, including higher costs and regulatory uncertainty. Manufacturing technologies like disposable bioreactors and chromatography can help lower costs. Close surveillance of originator products and demonstrating scalability are important. Post-approval changes will likely follow ICH Q5E guidelines. With scientific expertise and incremental innovations, biosimilar companies can successfully manage uncertainties in this emerging industry.
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This document provides an overview of biosimilars and their regulatory framework. It begins with definitions of biologics and biosimilars. Biosimilars are highly similar versions of approved biologics whose patents have expired. The development of biosimilars is unique compared to small molecule generics due to the complex nature of biologics. The document then discusses issues with biosimilars including potential efficacy, safety and substitution concerns. Finally, it provides details on the regulatory frameworks and guidelines established by organizations like WHO, EU, US and India to help facilitate the development and approval of biosimilars.
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This document discusses biosimilars and their regulation. It begins with a brief history of biotechnology and biopharmaceuticals. It then defines biosimilars as similar but not generic versions of biologic drugs whose patents have expired. The document outlines key differences between biosimilars and generic drugs, including their larger and more complex molecular structures. It also discusses concerns regarding biosimilar efficacy, safety, interchangeability, and pharmacovigilance. Finally, it provides an overview of regulatory frameworks for biosimilars in various regions like the EU, US, India, and WHO guidelines.
Bio similar- An opportunities or challenge for Indian Company
1. The global biosimilars market is expected to grow significantly in the coming years due to various drivers such as patent expiries of major biologics and increasing cost containment pressures.
2. Indian companies are well positioned in the biosimilars space due to their established low-cost manufacturing capabilities and expertise in biologics. Key players in India include Dr. Reddy's, Biocon, Cipla and Intas.
3. Developing biosimilars presents several challenges including high development costs, complex clinical trials and unclear regulatory guidelines. Indian companies strategy involves partnerships for cost-effective development and leveraging domestic capabilities and emerging markets for growth.
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Sharing my learning in dealing with complexity and uncertainty and shed some light on:
(a) Understanding the ‘biosimilar paradox’
(b) Accelerating our “QbD” Journey – focusing on ‘from Generics to Biosimilars’
(c) In preparing this talk, collect my thoughts to help NIPTE consider ways for developing its program on Biosimilars to help the Nation improve assurance of quality with confidence and lower costs
(D) Invite the audience to get to know NIPTE and provide us ways to collaborate with industry
FDA Presentation on Biologics
This document provides an overview of biological products as defined by the FDA. It describes biological products as medical products made from sugars, proteins, nucleic acids or complex combinations in living cells or tissues. Examples like vaccines, blood components and monoclonal antibodies are provided. The document highlights how biological products differ from chemically synthesized drugs in being large molecules from natural sources, requiring complex manufacturing processes, and sometimes being heterogeneous or immunogenic. It briefly outlines the process required for a biological product to be licensed by the FDA, including demonstrating consistent manufacturing and clinical safety and efficacy data.
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Date: June 29, 2016
Time: 1:00pm to 3:00pm EST
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This document provides a summary of the biosimilars pipeline in India over the next 3-5 years. It describes several biologic drugs whose patents will expire such as Avastin, Herceptin, Humira, Erbitux, and Remicade. The objective is to understand the competitive landscape as many global and Indian companies are aggressively developing biosimilars for these drugs. The document then provides details of an ongoing clinical trial in India of a rituximab biosimilar being developed by Hetero Drugs for the treatment of non-Hodgkin's lymphoma.
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Biosimilars are biopharmaceutical drugs that are similar to an original biologic drug, but are manufactured when the original drug's patent expires. Biosimilars must demonstrate similarity to the original product in terms of quality, safety and efficacy. India has advantages in manufacturing biosimilars due to lower costs and skilled workforce. Major Indian companies are developing biosimilars and targeting both domestic and international markets like the US and EU. Regulatory authorities in India approve and regulate biosimilars to ensure their safety and efficacy.
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This document discusses biosimilars in India and the opportunities and challenges in the biosimilars industry in India. It defines biosimilars and provides an overview of the global and Indian biosimilars market and regulatory landscape. The key opportunities for India include providing affordable treatment options and commercial benefits from lower cost manufacturing. However, challenges include regulatory hurdles, concerns around quality and safety, high development costs, and physician reluctance to prescribe biosimilars.
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This document provides an overview of biosimilars including their advantages and disadvantages. It discusses regulatory guidelines for biosimilar approval in India, challenges in biosimilar development and production, and recently approved biosimilars. The conclusion recognizes biosimilars as an important part of the pharmaceutical ecosystem but one that faces barriers to adoption such as questions of interchangeability and not having approval for all reference product indications. It recommends overcoming challenges to biosimilar market access.
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The document summarizes India's new guidelines for approval of biosimilar biologics. Some key points:
1) The guidelines define biosimilars as biological products claimed to be similar in safety, efficacy, and quality to an approved reference biologic.
2) Biosimilars are developed through analytical studies comparing properties to the reference product, which could reduce required clinical testing.
3) Clinical testing may include pharmacokinetic, pharmacodynamic, and safety/efficacy studies designed to establish comparability to the reference product. Post-market surveillance is also required.
4) The guidelines aim to balance regulatory standards with access to affordable biologics through a biosimilars pathway
Biosimilars
Biosimilars are biotherapeutic products that are similar to already approved reference biologics in terms of quality, safety and efficacy. They are developed to be highly similar but not identical to existing biologics. Regulatory agencies like EMA and FDA require extensive analytical, non-clinical and clinical studies including pharmacokinetic, immunogenicity and clinical efficacy trials to establish biosimilarity. While biosimilars could increase access and lower costs, issues related to efficacy, safety, substitution and labeling need to be addressed to ensure patient safety and appropriate use.
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This document provides information about an upcoming webinar on drug types including biosimilars and generics. It outlines details like the speaker, how to ask questions during the webinar, and instructions for accessing the webinar archive and following along on Twitter. It also provides brief bios of the speaker and gives technical instructions for participating in the webinar platform. Finally, it lists some resources and includes a standard disclaimer.
Drug development and discovery in biologics
This document provides an overview of drug development and discovery in biologics. It discusses key topics such as biologics and biosimilars, the integrated discovery and development process of antibodies, the market status and typical manufacturing process of biologics, their therapeutic roles and biological targets in therapy. Some of the challenges in biologics development include the complex manufacturing process, safety implications, immunogenicity, and limited shelf life. Regulations of biologics in India are outlined. Recent FDA-approved biologics are also mentioned. In conclusion, biologics and small molecules are seen as complementary approaches for drug development.
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Clinical development of biopharmaceuticals in India
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Drug Types: Biosimilars, generics and more. December 2017 Webinar 12122017
Drug Types: Biosimilars, generics and more. December 2017 Webinar 12122017
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U.S. Biosimilars - Red Flags for Patent Attorneys
The document discusses key issues for patent attorneys regarding biosimilar applications under the Biologics Price Competition and Innovation Act. It outlines the process for demonstrating biosimilarity and interchangeability to the FDA. It also summarizes the patent exchange process that is triggered by biosimilar applications, noting the short timeframes involved. The document advises patent holders to carefully review their portfolios and licensing agreements in preparation for biosimilar litigation given the tight deadlines of the patent exchange process.
Preparing for Biosimilars: Key Points for Participating in the U.S. Regulator...
Preparing for Biosimilars: Key Points for Participating in the U.S. Regulator...Knobbe Martens - Intellectual Property Law
In view of the U.S. approval process for biosimilars, companies are gearing up to either produce their own biosimilar products, or to defend against their entry onto the market. While the Biologics Price Competition and Innovation Act (BPCIA) spells out many of the requirements, the pathway for approval is complicated. Our panel of experts discuss the features of the BPCIA and how it operates for both approved biologics as well as biosimilar entrants. They also make some predictions on its impact for life science companies.
The webinar is 60 minutes, complete with Q&A.Patents & market exclusivity
This presentation explains concepts of Patents and Market Exclusivity. This presentation is compiled from publicly available material on the world wide web.
Claire Laporte, "Life Sciences IP"
Claire Laporte, "Life Sciences IP"The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics
January 23, 2017
The Fifth Annual Health Law Year in P/Review symposium featured leading experts discussing major developments during 2016 and what to watch out for in 2017. The discussion at this day-long event covered hot topics in such areas as health policy under the new administration, regulatory issues in clinical research, law at the end-of-life, patient rights and advocacy, pharmaceutical policy, reproductive health, and public health law.
The Fifth Annual Health Law Year in P/Review was sponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, Harvard Health Publications at Harvard Medical School, Health Affairs, the Hastings Center, the Program On Regulation, Therapeutics, And Law (PORTAL) in the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital, and the Center for Bioethics at Harvard Medical School, with support from the Oswald DeN. Cammann Fund.
Learn more on our website: http://petrieflom.law.harvard.edu/events/details/5th-annual-health-law-year-in-p-reviewSecuring Trade Secrets and Intellectual Property Against Cyberattack
The rise in cyber threats is putting companies at risk of losing trade secrets and other intellectual property assets that are integral to competitive edge, revenues and reputation. Many companies, however, are unsure about how to shore up their IP and trade secret protection programs to thwart potential risks and losses.
In this two-hour LIVE Webcast, a panel of distinguished professionals and thought leaders organized by The Knowledge Group will help the audience understand the important aspects of Securing Trade Secrets and Intellectual Property Against Cyberattack. They will provide an in-depth discussion of the critical issues and best practices with respect to this noteworthy topic. Speakers will also share helpful tips in developing and implementing data security programs while ensuring compliance with applicable laws.
Some of the major topics that will be covered in this course are:
IP and Trade Secrets Protection
Key Challenges and Vulnerabilities
Data Security Policies
Risk Identification and Mitigation
Best Regulatory Remedies
To view the webcast go to this link: https://youtu.be/neZTheov8LU
To learn more about the webcast please visit our website: http://theknowledgegroup.org
Kesselheim slides
This document discusses balancing pharmaceutical innovation and public health. It notes that while the current patent system incentivizes drug development, it can compromise access and public health goals in some cases. Problems include inappropriate patents, patents not rewarding true discoverers, and manipulation of regulations. Some areas like antibiotics face misaligned incentives as short courses are unlikely to be blockbusters. Proposed reforms address patent and regulatory abuse while ensuring important new drugs are created.
Biosimilars, Orphans, Advanced Therapy Medicines: Current regulatory issues (...
Biosimilars, Orphans, Advanced Therapy Medicines: Current regulatory issues (...Ioanna Michalopoulou
Get a quick, up to date overview of the Biotechnology industry and particularly "Red" Biotechnology and gain an understanding of the legal challenges the industry faces right now. Case studies, entrepreneurial examples and referrals to the current regulatory issues act as a starting point to delve deeper into that booming industry. Timo Minssen, "Regulatory exclusivities for pharmaceutical innovation in Europe"
Timo Minssen, "Regulatory exclusivities for pharmaceutical innovation in Europe"The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics
In the pharmaceutical industry, patents are the preeminent incentive for innovation in developing new drugs. But patents aren’t the whole story; regulatory agencies also offer different forms of exclusivity—enforced by the agencies themselves—to encourage different forms of innovation in the industry. This panel discussed actual and potential roles for those rewards in the context of developing new drugs, new uses for old drugs, and new ways to make drugs, in both the United States and the European Union. Biosimilars 10-21-2010
This document summarizes information about biosimilars and the regulatory pathways for their approval in the United States and European Union. It discusses how biosimilars differ from traditional small-molecule generics due to biological molecules' larger size, greater complexity, and manufacturing dependence. The U.S. passed the Biologics Price Competition and Innovation Act in 2010 to create an approval pathway for follow-on biologics, requiring biosimilarity demonstration and possible interchangeability labeling. Upcoming FDA hearings will provide information to guide biosimilar approval requirements regarding analytical and clinical data needs. The E.U. has approved several biosimilars under its regulatory framework established in 2005.
Non-Patent Exclusivities
This document discusses various types of non-patent market exclusivities that provide legal protection from generic competition for pharmaceutical companies. It describes five types of exclusivities in the US including orphan drug exclusivity which provides 7 years of protection, new chemical entity exclusivity with 5 years, new clinical study exclusivity for 3 years, pediatric exclusivity which extends existing protections by 6 months, and 180 days of exclusivity for being the first generic applicant to challenge a patent. The document also discusses exclusivity regimes in Europe including supplementary protection certificates and India's framework which does not guarantee data exclusivity.
Timeline of Biosimilars Pathways
The biosimilars frontier is still a fairly new market, but its regulatory beginnings can be traced back to the early 2000s, with Europe, Asia and Australia among the early adopters. See the attached document for a look at the global progress of biosimilars.
Get the latest on Biosimilars at https://www.smallworldsocial.com/biolink/
Curated resources updated daily.
Regulatory requirements for orphan drugs delivery
Regulatory requirements for orphan drugs delivery, Prof. Dr. Basavaraj K. Nanjwade, KLE University College of Pharmacy, Belgavi/Belgaum, Karnataka, India.
Monoclonal Antibodies Dawn Of A New Era
Seminar on IP and regulatory aspects, Brussels, 7 June 2012, speakers Michael Alt, Trevor Cook, Liz Fuller, Marc Martens (Bird & Bird) and Frank Landolt (Ablynx)
Pharma Product Portfolio 2011 210211
The document discusses pharmaceutical hot melt extrusion using twin screw extruders. It introduces Thermo Fisher Scientific's product portfolio of twin screw extruders for hot melt extrusion (HME) and twin screw granulation (TSG) applications. The miniLab, EuroLab, and Pharma series extruders are presented as solutions for various phases of product development, capable of processing batches from milligrams to kilograms. Regulatory and validation aspects of HME and options for continuous microscale production are also summarized.
Evergreening of patents in pharma field (Rahul Pokale)
Here are some examples of evergreening by Pharma companies illustrated with timeline.
It's Indian perspective.
A history of pharma v1
This document provides a high-level history and overview of the pharmaceutical industry from its roots in the Middle Ages to modern developments. Key events and innovations discussed include the merging of scientific and industrial revolutions in the 18th-19th centuries, major companies emerging to produce medicines at scale, key breakthrough drugs in the 1920s-1940s like insulin and penicillin, the rise of blockbuster drugs in the late 20th century, increasing government regulation and the growth of biologics patent cliffs facing major companies today.
New sources of big data for precision medicine: are we ready?
New sources of big data for precision medicine: are we ready?Health and Biomedical Informatics Centre @ The University of Melbourne
This document summarizes a presentation on new sources of big data for precision medicine. It discusses how new data sources like genomics, the human microbiome, epigenomics, and the exposome are generating large amounts of data. It then covers the evolution of precision medicine from concepts like personalized medicine and how strategic initiatives in the UK and US are supporting precision medicine research through funding programs and projects like the Cancer Genome Atlas, eMERGE, and exposome studies. The presentation raises the question of whether we are ready for precision medicine given these new data sources and research efforts.20121130 신약연구개발 동향 (한국형 신약 r&d open innovation 전략 심포지엄)
한국형 신약 R&D Open Innovation 전략 심포지엄 (한국화학연구원, 범부처신약개발사업단, 한국신약개발연구조합 주최, 한국화학연구원 주관)에서 발표 자료
Orphan drugs presentation
The document is a presentation about orphan drugs given by Dr. Atul Rajpara. It defines orphan drugs as those intended for the treatment of rare diseases or disorders. It discusses how rare diseases are defined in various countries and notes that over 7,000 rare diseases have been identified worldwide. The presentation outlines the Orphan Drug Act of 1983 in the US and its impact in incentivizing orphan drug development. It also discusses the orphan drug designation process and provides some examples of orphan drugs and their manufacturers. The presentation concludes by noting challenges to improving access to orphan drugs in India like affordability and a lack of incentives for drug developers.
Hatch Waxman Act
The Hatch Waxman Act established provisions to balance the interests of branded and generic drug manufacturers as well as consumers. It created the Abbreviated New Drug Application (ANDA) process to streamline generic approval. It also provides incentives like exclusivity periods and a 30 month stay on generic approval to encourage drug development while facilitating generic competition through the ANDA pathway. The Act aims to reduce drug costs over time through increased generic competition.
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Timo Minssen, "Regulatory exclusivities for pharmaceutical innovation in Europe"
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Evergreening of patents in pharma field (Rahul Pokale)
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New sources of big data for precision medicine: are we ready?
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20121130 신약연구개발 동향 (한국형 신약 r&d open innovation 전략 심포지엄)
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Similar to Biosimilars Law in Flux
What are Supergenerics
The document discusses supergenerics, which are generic drugs that offer improved features over existing generics. Supergenerics can provide a lower-risk alternative to developing new drugs and offer shorter development timelines compared to new chemical entities. The 505(b)(2) regulatory pathway allows supergenerics to incorporate existing clinical data, reducing development costs versus the traditional 505(b)(1) new drug application process. Supergenerics aim to create value through improved formulations, delivery methods, or other enhancements compared to existing generics while maintaining a known safety profile. This offers the potential for temporary market exclusivity and competitive advantages for generic drug companies.
E0421024026
The IOSR Journal of Pharmacy (IOSRPHR) is an open access online & offline peer reviewed international journal, which publishes innovative research papers, reviews, mini-reviews, short communications and notes dealing with Pharmaceutical Sciences( Pharmaceutical Technology, Pharmaceutics, Biopharmaceutics, Pharmacokinetics, Pharmaceutical/Medicinal Chemistry, Computational Chemistry and Molecular Drug Design, Pharmacognosy & Phytochemistry, Pharmacology, Pharmaceutical Analysis, Pharmacy Practice, Clinical and Hospital Pharmacy, Cell Biology, Genomics and Proteomics, Pharmacogenomics, Bioinformatics and Biotechnology of Pharmaceutical Interest........more details on Aim & Scope).
All manuscripts are subject to rapid peer review. Those of high quality (not previously published and not under consideration for publication in another journal) will be published without delay
The Drug Price Competition and Patent Term Restoration Act of 1984: The Basi...
Presentation at the Center for Professional Advancement (CFPA) Course on Generic Drug Approval, September 2009 at Teva Parenterals, with a focus on the key basic provisions of the 1984 Hatch-Waxman Act
Biosimilars: the New U.S. Pathway
Michael Swit presented at the RAPS Annual Conference in San Jose on October 25, 2010. He discussed the history of biologics regulation and the new pathway for biosimilars established by the Biologics Price Competition and Innovation Act of 2009. The new pathway allows for an abbreviated approval process for biosimilars but gives FDA flexibility in implementation. Biosimilars must show similarity to the reference product through analytical, animal, and clinical studies but may not need to repeat all studies. Interchangeability requires additional evidence and is not required for approval. FDA is seeking input on guidance and other implementation issues.
Donald R. Ware, Assessing the Viability of FDA's Biosimilars Pathway
Donald R. Ware, Assessing the Viability of FDA's Biosimilars PathwayThe Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics
February 18, 2016
The 2010 passage of the Biologics Price Competition and Innovation Act was intended to create a pathway for the approval of biosimilar drugs, to bring to market less expensive versions of innovators’ biologic therapeutics in the same way the Hatch-Waxman Act has worked so well for FDA approval of generic small-molecule drugs. But the Act has been mired in a host of statutory, regulatory, and scientific complication and delays, and five years later, the FDA has approved just one biosimilar product.
This panel discussion brought together experts from legal practice, industry, and academia to discuss each of these issues and to recommend ways in which the agency and industry can move forward.
For more information, visit the website: http://petrieflom.law.harvard.edu/events/details/viability-of-fda-biosimilar-pathway.INDA/NDA/ANDA
Introduction to Investigational new drug application, New drug application, Abbrevated new drug application
Biosimilars. Unpacking Complex Issues
This document discusses biosimilars, which are biologic drugs that are similar but not identical to already approved biologic drugs (reference biologics). It provides background on biologics and biosimilars, including that biosimilars take longer and cost less to develop than original biologics. Several regulatory issues for biosimilars are also discussed, such as naming, substitution, approval of indications, and reimbursement. The US recently approved its first biosimilar, but still lags behind Europe in approving and using biosimilars.
Regulatory guidance and guidelines for filing and approval for biologics
This document provides an overview of the regulatory guidance and guidelines for filing a Biologics License Application (BLA) with the FDA for approval of a biological product. It discusses the requirements for a BLA, including the contents that must be submitted. A BLA generally includes 20 sections that provide information on chemistry and manufacturing, nonclinical and clinical data, labeling, facilities and more. The document reviews the content required in each section and the review process by the FDA.
FDA Regulation of Biosimilars
This document summarizes a presentation about FDA regulation of biosimilars. It discusses how biosimilars differ from traditional generics due to biologics being more complex molecules than small molecule drugs. It outlines the key provisions of the Biologics Price Competition and Innovation Act of 2009, including requirements for biosimilar applications such as analytical, animal and clinical studies demonstrating biosimilarity to the reference product. It also discusses requirements for interchangeability and other miscellaneous rules regarding biosimilar approval pathways.
New Drug Application(Nda) Vs Abbreviated New Drug Application (Anda)
The document summarizes the key differences between a New Drug Application (NDA) and an Abbreviated New Drug Application (ANDA). An NDA is required for approval of new pharmaceuticals and contains extensive nonclinical and clinical data to establish safety and effectiveness. An ANDA is for generic drugs and contains bioequivalence data comparing it to an existing approved drug, but does not require new clinical trials. The review process is shorter for ANDAs compared to NDAs. The document also discusses patent certification requirements for ANDAs and exclusivity periods for orphan drugs.
INDA- Investigation New Drug Application
The document provides an overview of the Investigational New Drug Application (IND) and New Drug Application (NDA) processes required by the FDA to develop and approve new drugs. It describes how developing a new drug takes 15 years and over $900 million on average. The IND allows testing of new drugs in humans and provides safety data, while the NDA provides all clinical trial data for the FDA to determine if the drug is safe and effective for approval. Both the IND and NDA are lengthy applications that require extensive non-clinical and clinical data to gain FDA approval to market a new prescription drug.
Regulatory Requirements for API, Biologics and Novel therapies
Regulatory requirements for API
Regulatory requirements for Biologics
Regulatory requirements for Novel therapies
Biosimilars
The document discusses biosimilars and the regulatory pathway for biosimilar approval in India. It provides background on biosimilars and how they differ from generics in terms of manufacturing complexity and clinical development requirements. It summarizes India's draft biosimilar guidelines, including that phase III trials with 100+ patients are required for approval but phase I-II may be waived. The guidelines aim to streamline the process while aligning with global standards from the EMA and WHO. Over 20 biosimilars have been approved in India across several therapeutic classes.
pharma regulatory a
This document provides an overview of the global generic pharmaceutical industry and the regulatory process for approving generic drugs in the United States. It discusses key topics such as:
1) The size and growth of the global generic market compared to the overall pharmaceutical industry.
2) How the Hatch-Waxman Act of 1984 streamlined the generic drug approval process in the US through the ANDA pathway.
3) Potential issues with the Hatch-Waxman Act around "evergreening" patents and deals between brand and generic companies that delay generic competition.
Swapnil2
The document provides an overview of the global pharmaceutical industry and the generic drug market. It discusses how the generic drug market is growing faster than the overall pharmaceutical industry. It also summarizes the key requirements for FDA approval of generic drugs, including bioequivalence to the branded version. Additionally, it outlines the Hatch-Waxman Act which aims to balance generic and branded drug competition in the US market.
Q1 2015 Oncologistics_Sara Fernandez-Lopez_LinkedIn
The document discusses the FDA approval of the first biosimilar drug called Zarxio and the implications for oncology and hematology practices. It covers key topics like cost savings from competition, differences in safety/efficacy data requirements compared to original biologics, coverage by payers, coding of biosimilars, and reimbursement considerations. It also provides background on biosimilars versus generics, factors influencing adoption like physician preference and patient confidence, and how payers may encourage use of lower-cost biosimilars. The future approval of additional biosimilar applications is also addressed.
Biosimilar DDI HCP Webinar_June 20 2023 Final_3.pdf
This document provides information on biosimilars and interchangeable biosimilars for health care providers. It defines key terms like reference product, biosimilar, and interchangeable. It describes the FDA approval pathways for biosimilars and generics. The FDA recommends a comparative analytical assessment and targeted clinical studies to demonstrate biosimilarity or interchangeability to a reference product. Clinical studies generally show biosimilars and interchangeable biosimilars are equivalent to their reference products in terms of safety, efficacy, and immunogenicity, including after switching. To date, the FDA has approved 4 interchangeable biosimilars.
Final enforcement of biologics related patent under bpcia done
this presentation deals with the enforcement of biologics in the US and comparative study of NDA and BLA
EBR_October-15_pp.30-34 (Molekule)
This document discusses the biosimilar drug market and opportunities for biosimilar drug developers. It notes that as biologic drug patents expire, biosimilar drugs that are comparable in efficacy and safety to reference biologics at a lower cost represent a major market opportunity. However, biosimilar market uptake faces challenges from regulatory uncertainty, physician concerns about switching patients, and efforts by innovator companies to defend their biologic drugs. The document estimates that biosimilars may not achieve critical mass adoption until 2023-2025.
Anda 120822221703-phpapp01
An Abbreviated New Drug Application (ANDA) contains data to allow the FDA to review and approve a generic drug. The ANDA process provides a way for generic drug applications to be approved without requiring clinical trials by demonstrating bioequivalence to an existing brand name drug. The FDA reviews the ANDA for bioequivalence, chemistry and manufacturing controls, labeling, and conducts inspections to ensure quality before final approval of a generic drug.
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Regulatory guidance and guidelines for filing and approval for biologics
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Final enforcement of biologics related patent under bpcia done
Final enforcement of biologics related patent under bpcia done
Biosimilars Law in Flux
- 1. Biosimilars Law in Flux: An Update on U.S. Biosimilars Brian Dorn, Ph.D.